The purpose of the Validation & Compliance (3 Day) Training Programme is to provide learners with the opportunity of either taking one course alone, a mix of the following courses or all three in their entirety, over consecutive days.

The complete programme allows learners to build a basic knowledge of validation through to the latest GAMP® 5 guidance, and then on to specific American regulatory requirements for 21 CFR Part 11 Electronic Records; Electronic Signatures.

The programme comprises Understanding Validation Training (Day 1), GAMP® 5 Training - Fundamentals of GAMP® 5 Guidance Training (Day 2), and Interpreting 21 CFR Part 11 and Revised EU Annex 11 Training (Day 3).

• Investigate the history and requirements for validation
• What is validation?
• Regulatory requirements and expectations
• Understanding terms and the application of validation
  • Discuss the terms used
  • Evaluate the key stages of validation
  • Use the basic 'V' model for a simple approach
  • View a CD video and answer questions
  • How far does Good Engineering Practice go towards meeting compliance?
• Use case studies to explore the causes and implications of non compliant validation
• Analyse real scenarios
• Determine suitable actions for workplace improvements

Day 2

• Identify how GAMP® guidance was developed and the reasons behind it
• Regulatory requirements
• Technological innovation
• Interpretation of rules and regulations
• Review the Life Cycle approach and phases, including: Life cycle concepts; concept, project and retirement
• Practical examples based upon GAMP® categories of software
• Operational phases including:
• Handover
• CAPA
• Change management
• Security 
• System administration
• Latest terminology and common themes including, the relationship between qualification terminology and GAMP® 5 activities
• V model approach for IT systems and process control systems
• Categories of software, hardware and the validation approach
• Introducing Quality Risk Management
• An overview of Quality Risk Management
• Description of the risk assessment process including sample risk assessments
• Develop understanding of guidance for supplier activities
• Consider help for suppliers
• Describe regulated company activities to assure computerised system compliance
• Elements to achieve compliance
• Regulatory approach to audits and non-compliance
• Areas particularly vulnerable to non-compliance for manufacturers, and supplier considerations
• Review other GAMP® 5 guidance articles and appendices including:
• Guidance on efficiency improvements 
• Appendices: 
• Management
• Development
• Operation
• Special Interest Topics
• Other General Appendices

Day 3

• Understand what the regulation 21 CFR Part 11 is
  • What the requirements are
  • Why have the regulation?
  • The interpretation between guidance and regulation
• Identify key terminology used in the regulation
  • Terms and definitions
• Lifecycle of a document
  • Electronic
  • Hard copy
  • Records
• What is in and out of scope?
• Validation requirements for computer systems
• Predicate regulations - what are they, where to look and why?
• A focus on risk to records and the 'Hybrid' approach
• Links to validation
  • Validation requirements for computer systems
• Training
  • Requirements
  • Qualifications and experience
• Management of systems
  • For open and closed systems
  • Physical and logical controls
• Signatures
  • Signature/record linking
  • Their uniqueness
  • Biometrics
• Controls
  • Password ageing
  • Procedures
  • Management responsibilities
• Understand FDA Part 11 Guidance for Industry
  • Latest thinking and guidance
  • Why the FDA is now assessing whether companies are using the revised guidance
• Recall problems encountered by companies applying the rule
  • Potential problem areas
  • Case studies
  • Differing scenarios/FDA warning letter reviews
  • How the FDA used to audit and report compliance issues to where they are now
• Identify and review EU GMP Annex 11 revised guidance on Computerised Systems focusing on records and signatures
• Review includes:
• Corresponding GMP Volume 4 Guide, revision of Chapter 4 Documentation
• Updates from previous revision of Annex 11
• Cross reference to Part 11
• Describe the GAMP® approach to 21 CFR Part 11 compliance
• Links with GAMP® and risk assessment
• Use GAMP® risk assessment to assess a potential real scenario

ISPE owns the GAMP® trademark http://www.ispe.org/

This course can be delivered to a group of up to 12 delegates at your premises. Request a quote for an onsite course.

ITS offers onsite training courses delivered by an English-only speaking trainer for companies in Europe and Worldwide. ITS has delivered courses to delegates from a number of countries including Belgium, France, Germany, Ireland, Jordan, Russia, Sweden and Switzerland.

“Found the general overview very useful and the last session going through the V model – excellent.”
Open course delegate

“Trainer was very good at adapting course content to reflect the unique nature of our industry.”
Open course delegate

“Gave a good, clear understanding of a V model.”
Open course delegate

“Alan was quite happy to adapt his plans to suit the needs of attendees rather than sticking to a script.”
Open course delegate

“Very well run course. I got a lot out of it. Good venue and food a bonus.”
Open course delegate

“The course contents were interesting.”
Open course delegate

“Enjoyable course delivered at correct pace.”
Open course delegate

“Detailed course. The trainer was flexible with our needs and requirements”
Open course delegate

ITS’ Regulatory Training Manager, Alan Benbow, has developed extensive knowledge of this specialist area from 22 years’ industry experience working with Johnson & Johnson, and Wyeth Pharmaceuticals.

During his 14 years at Wyeth, Alan was involved in a wide range of activities including, at operational levels, developing operators, craftsmen, and technicians; he was also responsible for training and assessing operational employees to NVQ standards. From a mid-management perspective, training and development initiatives included facilitating continuous improvement projects and best practices, and receiving internal recognition awards. more ›